Intestinal Barrier Function and Liver Cirrhosis - Full Text View

Sponsor:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT01081236

Purpose

Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis.

The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.

Condition
Liver Cirrhosis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Role of the Intestinal Barrier Function in Liver Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess tight junction structure and proteins in biopsy specimens of small and large intestine [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Compensated liver cirrhosis
Decompensated liver cirrhosis

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population will be selected from a hospital providing both secondary and tertiary care

Criteria

Inclusion Criteria:

Liver cirrhosis of any cause
A score of greater-than or equal to 5 assessed according to the Child-Pugh classification
Age between 18 and 65 years

Exclusion Criteria:

Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus
Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081236

Contacts

Contact: Kirsten Pijls, MD

+31433882157

k.pijls@intmed.unimaas.nl

Locations

Netherlands
Maastricht University Medical Center	Recruiting
Maastricht, Limburg, Netherlands
Contact: Kirsten Pijls, MD 0031433882157 k.pijls@maastrichtuniversity.nl
Principal Investigator: Ad Masclee, MD PhD
Sub-Investigator: Kirsten Pijls, MD

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator:

A Masclee, MD, PhD

Maastricht University Medical Center

More Information

No publications provided

Responsible Party:	Prof. dr. A. Masclee, Maastricht University Medical Center, Division of Gastroenterology-Hepatology
ClinicalTrials.gov Identifier:	NCT01081236 History of Changes
Other Study ID Numbers:	MEC 09-2-125
Study First Received:	March 4, 2010
Last Updated:	December 15, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

liver cirrhosis
intestinal permeability
microbiota
complications

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012